Hydrocodone/Acetaminophen on Extended Release — Competitive Intelligence Brief

Hydrocodone/Acetaminophen on Extended Release (Hydrocodone/Acetaminophen on Extended Release) competitive landscape: 6 comparators, recent regulatory actions, upcoming PDUFA, patent timeline. Class: Opioid analgesic combination. Area: Pain Management.

phase 3 Opioid analgesic combination Mu opioid receptor (hydrocodone); COX inhibitor (acetaminophen) Pain Management Small molecule

Target snapshot

Hydrocodone/Acetaminophen on Extended Release (Hydrocodone/Acetaminophen on Extended Release) — Abbott. Hydrocodone is an opioid agonist that binds to mu opioid receptors in the central nervous system to reduce pain, while acetaminophen inhibits prostaglandin synthesis to provide additional analgesic and antipyretic effects.

Comparator set (6 drugs)

Drug	Generic	Sponsor	Phase	Class	Target	Approval / PDUFA
Hydrocodone/Acetaminophen on Extended Release TARGET	Hydrocodone/Acetaminophen on Extended Release	Abbott	phase 3	Opioid analgesic combination	Mu opioid receptor (hydrocodone); COX inhibitor (acetaminophen)
BENZHYDROCODONE	BENZHYDROCODONE		marketed	Opioid analgesic combination; full mu-opioid agonist with non-opioid analgesic	Mu-opioid receptors (primary); delta and kappa opioid receptors (secondary); central nervous system pain pathways	2018-01-01
Bupivacaine-fentanyl elective group	Bupivacaine-fentanyl elective group	Conrad Arnfinn Bjørshol	marketed	Local anesthetic with opioid analgesic combination	Voltage-gated sodium channels (bupivacaine); mu opioid receptor (fentanyl)
lidocaine and sufentanil	lidocaine and sufentanil	RenJi Hospital	marketed	Local anesthetic and opioid analgesic combination	Voltage-gated sodium channels (lidocaine); mu opioid receptor (sufentanil)
Acetaminophen-Hydrocodone	Acetaminophen-Hydrocodone	Le Bonheur Children's Hospital	marketed	Opioid analgesic combination	Mu opioid receptor (hydrocodone component); prostaglandin synthesis inhibition (acetaminophen component)
Tramadol HCl-Paracetamol	Tramadol HCl-Paracetamol	Xian-Janssen Pharmaceutical Ltd.	marketed	Opioid analgesic combination	Opioid receptors (μ, δ, κ); monoamine transporters (norepinephrine, serotonin); cyclooxygenase enzymes
Codeine/acetaminophen	Codeine/acetaminophen	Montefiore Medical Center	marketed	Opioid analgesic combination	Mu-opioid receptor (codeine); COX enzymes (acetaminophen)

Recent regulatory actions (last 90 days)

No regulatory actions in the last 90 days for this set.

Upcoming PDUFA dates (next 180 days)

No PDUFA dates in the next 180 days for this set.

Patent timeline (forward window)

No upcoming patent expiries for this set.

Sponsor landscape (Opioid analgesic combination class)

1. VA Office of Research and Development · 3 drugs in this class
2. Rothman Institute Orthopaedics · 2 drugs in this class
3. Labopharm Inc. · 2 drugs in this class
4. University of Rochester · 2 drugs in this class
5. Montefiore Medical Center · 2 drugs in this class
6. Maastricht University Medical Center · 2 drugs in this class
7. Henry Ford Health System · 1 drug in this class
8. Daewon Pharmaceutical Co., Ltd. · 1 drug in this class
9. Albert Einstein College of Medicine · 1 drug in this class
10. Johnson & Johnson Taiwan Ltd · 1 drug in this class